(42 days)
The VERSIFLEX is intended to visualize anatomical structures by converting a pattern of x-radiation into an image through electronic amplification and recording, and, when used with injection of contrast medium, to visualize the heart or blood vessels.
The Hitachi VERSIFLEX is a new product. The VERSIFLEX is a multidirectional fluoroscopic/angiographic and radiographic system, incorporating a C-arm supporting base and an integrated patient tilting table into one system. With this system it is possible to carry out fluoroscopic/angiographic or radiographic examinations from various angles, and in combination with an X-ray generating unit and an image processing system, it can be used for multi-purpose examinations.
The provided document is a 510(k) summary for the Hitachi Versiflex, a fluoroscopy/angiography system. It asserts substantial equivalence to a predicate device and details the intended use and technological characteristics. However, it does not contain the specific information requested regarding acceptance criteria, device performance, study design, or ground truth establishment.
Therefore, I must state:
**The provided document does not contain the information required to complete the request regarding acceptance criteria and the study that proves the device meets those criteria. Specifically, the document is a 510(k) summary focused on substantial equivalence to a predicate device, and it does not include details on: **
- A table of acceptance criteria and reported device performance
- Sample sizes used for test sets
- Data provenance for test sets
- Number and qualifications of experts for ground truth establishment
- Adjudication methods
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study results or effect sizes
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document only states that "The VERSIFLEX is being tested to UL-2601 and will not be marketed until the testing reaches a successful conclusion," which indicates safety testing, not performance criteria related to diagnostic accuracy or clinical effectiveness. The core of this 510(k) is a comparison of technological characteristics to a predicate device, not a performance study against specific acceptance criteria.
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510(k) Summary
Hitachi Versiflex
Common/Classification Name: System, 21 CFR 892.1650, 892.1650
Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, OH 44087-2371
330-425-1313, 330-425-1410 (FAX) Contact: John T. Newland, Prepared: March 19, 1999
LEGALLY MARKETED PREDICATE DEVICES A.
The Hitachi VERSIFLEX is substantially equivalent to the presently marketed Hitachi SX-VA30 Fluoroscopy/Angiography System (as cleared in K964990). The VERSIFLEX is manufactured by Hitachi Medical Corporation, Hitachi Hagoromo Building, 1-2-10 Uchi-Kanda, Chiyoda-Ku, Tokyo, 101, Japan. This 510(k) is submitted because the VERSIFLEX is a new device.
DEVICE DESCRIPTION B.
The Hitachi VERSIFLEX is a new product. The VERSIFLEX is a multidirectional fluoroscopic/angiographic and radiographic system, incorporating a C-arm supporting base and an integrated patient tilting table into one system. With this system it is possible to carry out fluoroscopic/angiographic or radiographic examinations from various angles, and in combination with an X-ray generating unit and an image processing system, it can be used for multi-purpose examinations.
C. INTENDED USE
The VERSIFLEX is intended to visualize anatomical structures by converting a pattern of x-radiation into an image through electronic amplification and recording, and, when used with injection of contrast medium, to visualize the heart or blood vessels.
D. SUBSTANTIAL EQUIVALENCE SUMMARY
The Hitachi VERSIFLEX has an indications for use statement that is
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almost identical to that of the legally marketed predicate device. That is, it has the same intended use. The Hitachi VERSIFLEX has the "same technological characteristics" as the predicate devices, and these characteristics are sufficiently precise to assure substantial equivalence.
TECHNOLOGICAL CHARACTERISTICS E.
The technological characteristics of the Hitachi VERSIFLEX are the same as for the SX-VA30 C-Arm Floroscopic/Angiographic System.
F. TESTING
The VERSIFLEX is being tested to UL-2601 and will not be marketed until the testing reaches a successful conclusion.
CONCLUSIONS G.
Hitachi Medical Systems America has demonstrated that the Hitachi VERSIFLEX is substantially equivalent to the Hitachi SX-VA30 Fluoroscopy/Angiography System.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle, there is a stylized image of three human profiles facing to the right, represented by curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 1999
Hitachi Medical Corporation C/O Whit Athey, Ph.D. Senior Consultant C.L. Macintosh & Associates, Inc. Medical & Regulatory Affairs Services 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852
Re:
K991231 Hitachi Versiflex Dated: April 12, 1999 Received: April 12, 1999 Regulatory Class: II 21 CFR 892.1600/Procode: 90 IZI 21 CFR 892.1650/Procode: 90 JAA
Dear Mr. Athey:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Indications For Use:
The SF-VA200 is intended to visualize anatomical structures by converting a pattern of x-radiation into an image through electronic amplification and recording, and, when used with injection of contrast medium, to visualize the heart or blood vessels.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Bergman
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_K991231
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.